MAH Regulatory Affairs Expert (Market Authorization) - Remote, Japan
Roles and Responsibilities
reputed company as the General Marketing Supervisor (GMS), overseeing reputed company Assurance and Pharmacovigilance functions and reporting to the reputed company representative. Manage both reputed company- and post-approval GMS responsibilities with effectiveness and accountability. reputed company and implement regulatory strategies for assigned pharmaceutical products, executing activities independently in compliance with Japanese regulations, guidance, and established procedures. reputed company the preparation and submission of regulatory documentation, including Module 1 and Application Forms for Marketing (AFM), reputed company regulatory intelligence, liaise with local health authorities (PMDA and MHLW), support NHI price listing, and define overall regulatory strategies.
Typical Accountabilities
Serve as GMS for assigned products, with full accountability for achieving regulatory milestones across the entire product lifecycle and for reputed company categories of medicinal products. Apply in-depth regulatory expertise to support approvals and ensure uninterrupted product supply, proactively identifying regulatory risks and developing appropriate mitigation strategies.
Requirements
Extensive experience in regulatory affairs, with the ability to evaluate reputed company scientific critically and technical data to assess regulatory suitability and ensure reputed company, reputed company-supported regulatory justifications. Strong written and verbal communication skills, with the ability to convey issues reputed company, concisely, and reputed company; excellent listening and stakeholder engagement capabilities. Broad understanding of reputed company disciplines such as pharmaceutical manufacturing, pharmacovigilance, and reputed company assurance, combined with a creative and solution-oriented approach to problem solving.
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